DIGITAL SPY
DIGITAL
NEWS UPDATE
spy MEDTECH UPDATE
www.polyone.com
PolyOne develops alternative TPE to silicone
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olyOne, a global polymer material provider, has developed an alternative ThermoPlastic Elastomer (TPE) to silicone. There was a real need for an alternative following the FDA’s reports of siloxane shortages - a key ingredient in silicone. Additionally, the news regarding the closure of ethylene oxide facilities was resulting in longer lead times and higher prices for medical tubing. In response, PolyOne launched its Versaflex HC BT218 at MD&M West earlier this year. The company claims the material is able to deliver the critical demands for biopharmaceutical tubing applications, including weldability, kink resistance and tensile strength performance to the same standard as silicone and
other TPEs. Jim Mattey, global marketing director, specialty engineered materials commented: “We’re excited to add the new Versaflex grade to our expanding set of solutions that enable customers to continue pursuing product innovation and meet market demands.” He added: “We are committed to leveraging our material science expertise to formulate alternative and customised solutions that meet regulatory demands and functional necessity for life-saving medical devices, especially in the face of market uncertainties.” The material is currently available in the United States and has been submitted for USP class VI and ISO 10993-4,5 certifications.
WWW.SKYRORA.COM
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www.skyrora.com plastic POWER
kyora, a rocket launch start-up based in Edinburgh, UK, has successfully tested a 3D-printed rocket engine using power from plastic waste. “Ecosene” is the name given to this new type of fuel which the company claims is making its vehicles greener and more ecologically sound than competition. Skyora says it can create around 600kg of kerosene from 1000kg of plastic waste, whilst
REGULATORY UPDATE
ec.europa.eu
NSAI NAMED AS A NOTIFIED BODY
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ational Standards Authority of Ireland (NSAI) was awarded Notified Body (NB) status under the new EU Medical Device Regulation (MDR) which comes into effect on 26th May 2020. The new regulation consists of stringent requirements around devices, clinical data and post-market surveillance. As part of its role as a NB, the NSAI is now able to inspect medical devices and other products for safety and compliance. Having a NB within Ireland means that multinationals and local businesses will be able to have their devices checked in Ireland. Currently there are only ten other NBs. This is thought to be because all NBs require approval by European officials. A delay by the European Commission has meant there are much fewer NBs at this stage
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also stating that its fuel results in around 45% less greenhouse gas emissions. A key benefit of Ecosene is that it can be stored in tanks for long periods of time as it doesn’t require cryogenic freezing. Volodymyr Levykin, CEO of Skyrora said the fuel had transformative potential for the entire space sector. The company believes the results are encouraging with its first vehicles set to fly in 2022 from the UK based launch site.
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than anticipated. For example, the NSAI applied in November 2017 (over two years ago). A shortage of NBs could result in a large number of devices not being re-certified in time, and therefore possible shortages.
